Snap-on vascular closure device and methods

ABSTRACT

A tissue puncture closure assembly including a wire assembly and a sealing pad delivery device. The wire assembly includes a proximal end portion, a distal end portion, and a temporary expandable anchor positioned at the distal end portion. The sealing pad delivery device includes a carrier tube, a sealing pad positioned in the carrier tube, and a lateral wire slot. The lateral wire slot is defined in an outer surface of the sealing pad delivery device and extends along at least a portion of a length of the sealing pad delivery device. The lateral wire slot is configured to permit mounting of the sealing pad delivery device to the wire assembly in a lateral direction.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of the filing date of U.S.Provisional Application No. 61/466,775, filed 23 Mar. 2011, and entitledSNAP-ON VASCULAR CLOSURE DEVICE AND METHODS, the disclosure of which ishereby incorporated in its entirety by this reference.

TECHNICAL FIELD

The present disclosure relates generally to medical devices and moreparticularly to vascular closure devices.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly orintraluminally. For example, in the treatment of vascular disease, suchas arteriosclerosis, it is a common practice to access the artery andinsert an instrument (e.g., a balloon or other type of catheter) tocarry out a procedure within the artery. Such procedures usually involvethe percutaneous puncture of the artery so that an insertion sheath maybe placed in the artery and thereafter instruments (e.g., a catheter)may pass through the sheath and to an operative position within theartery. Intravascular and intraluminal procedures unavoidably presentthe problem of stopping the bleeding at the percutaneous puncture afterthe procedure has been completed and after the instruments (and anyinsertion sheaths used therewith) have been removed. Bleeding frompuncture sites, particularly in the case of femoral arterial punctures,may be stopped by utilizing vascular closure devices, such as thosedescribed in U.S. Pat. Nos. 6,090,130 and 6,045,569, which are herebyincorporated in their entireties by this reference.

Typical closure devices such as the ones described in theabove-mentioned patents place a sealing plug at the tissue puncturesite. Deployment of the sealing plug may involve ejecting the sealingplug from within the closure device sheath to a location in alignmentwith and adjacent to the tissue puncture along an outer surface of thevessel and within a percutaneous tissue tract. Mounting the closuredevice onto a proximal end of the guidewire and advancing the closuredevice to the tissue puncture site may require both of the operator'shands. However, in at least some treatment procedures, one of theoperator's hands is used to apply and maintain pressure to the patientadjacent to the tissue puncture to provide hemostasis and hold theguidewire within the vessel. Releasing the operator's hand from applyingpressure to the patient may result in complications in the procedure.Opportunities exist for improvements in this technical area.

SUMMARY

One aspect of the present disclosure relates to a tissue punctureclosure assembly that includes a wire assembly and a sealing paddelivery device. The wire assembly includes a proximal end portion, adistal end portion, and a temporary expandable anchor positioned at thedistal end portion. The sealing pad delivery device includes a carriertube, a sealing pad positioned in the carrier tube, and a lateral wireslot. The lateral wire slot is defined in an outer surface of thesealing pad delivery device and extends along at least a portion of alength of the sealing pad delivery device. The lateral wire slot isconfigured to permit mounting of the sealing pad delivery device to thewire assembly in a lateral direction.

The lateral wire slot may be configured to provide a snap-fit connectionof the sealing pad delivery device to the wire assembly. The sealing paddelivery device may further include a housing, and the lateral wire slotis formed in outer surfaces of the housing, the carrier tube, and thesealing pad. The wire assembly may further include a handle positionedat the proximal end portion and an anchor actuator mounted to thehandle. The wire assembly may include a tubular portion having a lumenand a wire member positioned in the lumen, wherein relative movementbetween the tubular portion and the wire member expands and contractsthe anchor. The wire assembly may further include an anchor actuatorpositioned at the proximal end portion and configured to move the wiremember relative to the tubular portion. The sealing pad delivery devicemay include a wire lumen sized to receive a portion of the wire assemblythat is located between the distal and proximal end portions, and theproximal end portion of the wire assembly is sized greater than the wirelumen.

Another aspect of the present disclosure relates to a tissue punctureclosure device adapted for insertion into and sealing of a tissuepuncture in a tissue wall. The device includes a housing, a carrier tubeextending from the housing, a sealing pad positioned in the carriertube, a guidewire lumen, and a lateral guidewire slot. The guidewirelumen extends through the housing and carrier tube. The lateralguidewire slot is open from an outer side surface of the closure deviceinto the guidewire lumen. The closure device is operable to mount to aguidewire that is positioned in the tissue puncture by inserting theguidewire through the lateral guidewire slot and into the guidewirelumen.

A portion of the guidewire located between proximal and distal ends ofthe guidewire may be inserted into the lateral guidewire slot. Thesealing pad may include a slot feature arranged in alignment with thelateral guidewire slot. The closure device may further include a wirelocking member operable to resist axial movement of the closure devicerelative to the guidewire. The closure device may also include a tuberetractor actuator that is operable to withdraw the carrier tuberelative to the housing to expose the sealing pad. The lateral guidewireslot may include a tapered construction. The lateral guidewire slot maybe configured to provide a snap-fit connection between the guidewire andthe closure device.

Another aspect of the present disclosure relates to a method of sealinga tissue puncture in an internal tissue wall that is accessible througha percutaneous incision. The method may include providing a closuredevice and a guidewire, the closure device including a sealing pad and alateral guidewire slot, and the guidewire including distal and proximalends. The method may also include advancing a distal end of theguidewire through the percutaneous incision and the tissue puncture, andmounting the closure device to the guidewire by inserting a portion ofthe guidewire spaced between the distal and proximal ends of theguidewire through the lateral guidewire slot.

Mounting the closure device may include arranging the closure devicelaterally adjacent to the guidewire with the lateral guidewire slotaligned facing the guidewire, and moving the closure device in a lateraldirection toward the guidewire. The guidewire may include a handlepositioned at a location proximal of the percutaneous incision when thedistal end of the guidewire is advanced through the percutaneousincision and the tissue puncture, and mounting the closure device to theguidewire includes mounting the closure device to the guidewire at alocation distal of the handle. The lateral guidewire slot may be definedat least in part by the sealing pad, and mounting the closure device tothe guidewire includes inserting the guidewire into the sealing pad. Themethod may also include operating the closure device to expose thesealing pad in the percutaneous incision and withdrawing the guidewirethrough the exposed sealing pad. The closure device may include acarrier tube and a housing, the lateral guidewire slot being defined inthe carrier tube and housing, and mounting the closure device to theguidewire includes inserting the guidewire into the carrier tube andhousing.

Additional advantages and novel features will be set forth in thedescription which follows or may be learned by those skilled in the artthrough reading these materials or practicing the examples disclosedherein.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentdisclosure and are a part of the specification. The illustratedembodiments are merely examples and are not intended to be limiting.

FIG. 1 is a side view of an example closure device in the prior artbeing mounted to a guidewire by inserting a proximal end of theguidewire to a distal end of the closure device.

FIG. 2 is a side view of the closure device of FIG. 1 advanced into apercutaneous incision.

FIG. 3 is a side view of an example closure device in accordance withprinciples of the present disclosure.

FIG. 3A is a cross-sectional view of the closure device of FIG. 3 takenalong cross-section indicators 3A-3A.

FIG. 4 is a side view of an example guidewire in accordance withprinciples of the present disclosure inserted through a tissue punctureand percutaneous incision.

FIG. 4A is a cross-sectional view of the guidewire shown in FIG. 4 takenalong cross-section indicators 4A-4A.

FIG. 5 is a side view of the closure device of FIG. 3 positionedlaterally adjacent to the guidewire of FIG. 4.

FIG. 6 is a side view of the closure device of FIG. 5 moved laterally toa mounted position on the guidewire of FIG. 5.

FIG. 7 is a side view of the closure device of FIG. 6 advanced over theguidewire and into the percutaneous incision.

FIG. 8 is a side view of the closure device of FIG. 7 with the closuredevice operated to expose a sealing pad within the percutaneousincision.

FIG. 9 is a side view of the guidewire FIG. 8 being operated to collapsethe anchor of the guidewire.

FIG. 10 is a side view of the guidewire FIG. 9 being withdrawn out ofthe closure device.

FIG. 11 is a side view of the closure device of FIG. 10 being withdrawnout of the percutaneous incision.

FIG. 12 is a partial cross-sectional view of a portion of the guidewireshown in FIG. 4.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

As mentioned above, vascular procedures are conducted throughout theworld and require access to a vessel through a puncture. Often, thevessel is a femoral artery. To close the puncture following completionof the procedure, a closure device may be used to position a sealing padwithin a percutaneous incision adjacent to the puncture. The closuredevice may be advanced over a guidewire that is positioned extendingthrough the percutaneous incision and the puncture. The guidewire mayinclude a temporary anchor feature that is expandable within the vesselto provide an anchoring, locating and/or sealing function internal tothe vessel, and returns to an unexpanded state for removal of theguidewire through the percutaneous incision and puncture after thesealing plug has been positioned in the percutaneous incision.

Advancing the closure device over the guidewire to the percutaneousincision typically involves inserting a proximal end of the guidewireinto a distal opening of the dilator and closure device at a locationthat is spaced relatively far from the percutaneous incision. Because ofthe relatively flexible nature of the guidewire and the distance fromthe percutaneous incision to the proximal end of the guidewire, both ofthe operator's hands are usually needed to mount the closure device tothe guidewire and withdraw the dilator and closure device from off theproximal end of the guidewire. If both of the operator's hands areneeded to mount the closure device to the guidewire, it may be difficultfor the operator to perform other aspects of the patient treatment suchas applying pressure to the patient adjacent to the percutaneousincision to create hemostasis and/or retain a distal end of theguidewire in the puncture.

Some guidewires include a temporary expandable anchor that is positionednear a distal end of the guidewire. The anchor may have a collapsedstate or position that permits passing of the anchor and distal end ofthe guidewire through the incision and puncture (i.e., into a vessellumen). The guidewire may include actuator features positioned outsideof the patient that are operable to move the anchor into an expandedstate or position. A size of the anchor when in the expanded statelimits withdrawal of the anchor out of the puncture. The anchor mayprovide a sealing and anchoring function when in the expanded state. Theactuator features of the guidewire are typically sized small enough thatthe closure device may be advanced over the proximal end of theguidewire with the actuator features passing through an interior of theclosure device. Actuator features of this relatively small size may bedifficult for the operator to handle such as when the operator moves theactuator features to expand and collapse the anchor during treatment ofthe patient.

Referring to FIGS. 1 and 2, an example tissue puncture treatmentassembly 200 that involves advancing a closure device 202 (also referredto herein as a sealing pad delivery device) over a guidewire 206 (alsoreferred to herein as a locator wire assembly) is shown and described.The guidewire 206 has a distal end portion 242 that is inserted througha percutaneous incision 118 and a vessel puncture 114 (also referred toherein as a tissue puncture) until a temporary anchor 248 of theguidewire is positioned in a vessel interior 116 at a location distal ofthe vessel puncture 114. A pair of actuator features 250, 252 at aproximal end portion 244 of the guidewire may be operated to expand theanchor 248 into the expanded state shown in FIGS. 1 and 2.

The closure device 202 is shown in FIG. 1 positioned proximal of theproximal end portion 244 of the guidewire 206. Mounting the closuredevice 202 to the guidewire 206 includes inserting the proximal endportion 244 (including the actuator features 250, 252) into an opendistal end 234 of the closure device 202. The closure device 202 isadvanced along the guidewire 206 until the open distal end 234 of thecarrier tube is inserted into the percutaneous incision 118. The closuredevice 202 may then be operated to deploy a sealing pad (not shown inthe figures) within the percutaneous incision 118 at a location adjacentto the vessel puncture 114.

Typically, the actuator features 250, 252 are sized small enough to passthrough the open distal end 234 of the closure device 202 and thesealing pad (not shown in FIG. 1) carried in the closure device 202.Operating actuator features 250, 252 of this relatively small size toexpand and/or contract the anchor 248 may be difficult for the operatorto conduct with the precision and accuracy needed.

The devices and methods of the present disclosure may provide theoperator with the ability to advance and withdraw the closure deviceover the guidewire using one hand as part of treating the patient. Theoperator's other hand may be used to maintain pressure on the patientadjacent the tissue tract, for example, to limit blood flow through avessel of the patient being treated or to hold a distal end of theguidewire within the vessel being treated.

Further, the devices and methods disclosed herein may provide anchoractuator features of increased size that may be easier for the operatorto handle when expanding and contracting the anchor.

In at least one example, the closure device is configured to mount tothe guidewire in a lateral direction rather than solely in an axialdirection. Such lateral mounting of the closure device may make itpossible to mount the closure device to the guidewire at a locationdistal of the anchor actuator features so that the anchor actuatorfeatures do not have to pass through interiors of the closure device andsealing pad. In at least one arrangement, the anchor actuator featuresmay include a handle portion that has improved ergonomics and anactuator feature that moves relative to the housing that has improvesease of use for the operator.

While the vascular instruments shown in the attached figures anddescribed below may include procedural sheaths and puncture sealingdevices, the application of principles described herein are not limitedto the specific devices shown. The principles described herein may beused with any medical device. Therefore, while the description below isdirected primarily to vascular procedures and certain embodiments of avascular closure device, the methods and apparatus are only limited bythe appended claims. Applications of closure devices including thoseimplementing principles described herein include closure of apercutaneous puncture or incision in tissue separating two internalportions of a living body, such as punctures or incisions in bloodvessels, ducts or lumens, gall bladders, livers, hearts, etc.

As used in this specification and the appended claims, the term“compact” or “compacting” is used broadly to mean any type of tamping(i.e., packing down by one or a succession of blows or taps or smooth,steady pressure, but not by excessive force), compacting, orcompressing. The term “engage” and “engageable” are also used broadly tomean interlock, mesh, or contact between two devices. Likewise“disengage” or “disengageable” means to remove or capable of beingremoved from interlock, mesh, or contact. A “tube” is an elongateddevice with a passageway. The passageway may be enclosed or open (e.g.,a trough). A “lumen” refers to any open space or cavity in a device orbodily organ, especially in a blood vessel. The words “including” and“having,” as used in the specification, including the claims, have thesame meaning as the word “comprising.”

Referring now to FIGS. 3-12, an example tissue puncture treatmentassembly 100 (see FIGS. 5-10) is shown and described. The tissuepuncture treatment assembly 100 includes a sealing pad delivery device102 (also referred to herein as a “closure device 102”), and locatorwire assembly 106 (also referred to herein as a “guidewire 106”). Thesealing pad delivery device 102 is configured to deliver a sealing padto a tissue puncture. In at least one example, the sealing pad deliverydevice 102 delivers a sealing pad to a position adjacent to and proximalof a vessel puncture and within a percutaneous incision. The locatorwire assembly 106 is typically pre-positioned extending through thetissue puncture and used as a guiding device over which the sealing paddelivery device 102 may be advanced into position adjacent to the tissuepuncture.

FIG. 3 illustrates the sealing pad delivery device 102 in a close upside view. The sealing pad delivery device 102 includes a housing 120, acarrier tube 122 extending within and distally from the housing 120(e.g., see FIG. 3A), and a sealing pad 126 positioned in the carriertube 122. The sealing pad delivery device 102 may also include a wirelocking member 128 that is configured to releasably lock the sealing paddelivery device 102 to the guidewire 106, and a tube retractor actuator130 that moves the carrier tube 122 relative to the housing 120 (e.g.,into handle 120) to expose the sealing pad 126 outside of the sealingpad delivery device 102. Other types of devices may be used in place ofor in combination with the wire locking member 128 and the retractoractuator 130 to limit relative axial movement between the guidewire 106and sealing pad delivery device 102 and dispose the sealing pad 126adjacent to the tissue puncture.

The sealing pad delivery device 102 may further include a lateral wirelumen slot 132. The lateral wire lumen slot 132 may be configured forinsertion of the guidewire into the sealing pad delivery device 102 in alateral or radial direction rather than insertion through an open end inan axial direction as described above with reference to the embodimentof FIGS. 1 and 2. The lateral wire lumen slot 132 may extend alongsubstantially the entire length L of the sealing pad delivery device102. In other arrangements, the lateral wire lumen slot 132 extendsalong only a portion of the length L, such as long only the carrier tube122. The lateral wire lumen slot 132 may be defined in part by both thehousing 120 and the carrier tube 122. In some arrangements, the sealingpad 126 also includes a wire lumen 134 and a lateral slot opening 136(see FIG. 8). Typically, the lateral slot opening 136 of the sealing pad126 is radially aligned with the lateral wire lumen slot 132 such thatinsertion of the guidewire 106 into the lateral wire lumen slot 132results in positioning of the guidewire 106 within the wire lumen 134 ofthe sealing pad 126.

Once the locator wire assembly 106 is inserted through the lateral wirelumen slot 132 and into wire lumen 123 of the sealing pad deliverydevice 102 (see FIG. 3A), the sealing pad delivery device 102 may beadvanced and withdrawn axially relative to the locator wire assembly 106as will be described in further detail below.

The lateral wire lumen slot 132 may be configured with a tapered orsloped opening as shown in FIG. 3A. The tapered construction of thelateral wire lumen slot 132 may be helpful in initially locating thelocator wire assembly 106 within the lateral wire lumen slot 132 as thelocator wire assembly 106 is moved laterally into the wire lumen 123.

The construction of the lateral wire lumen slot 132 in combination with,for example, the cross-sectional shape, material composition, and otherphysical properties of the sealing pad delivery device 102 may influencethe ease or difficulty of inserting the locator wire assembly 106 intothe wire lumen 123 in the lateral direction. For example, the generallytapered construction of the lateral wire lumen slot 132 shown in FIG. 3in combination with a material composition that provides flexibility forthe sealing pad delivery device 102 may result in some spreading open ofthe lateral wire lumen slot 132 as the locator wire assembly 106 isinserted, followed by return back to the original shape once the locatorwire assembly 106 is positioned within the wire lumen 123.

In some arrangements arrangements, the sealing pad delivery device 102provides a snap-fit interface between the sealing pad delivery device102 and the locator wire assembly 106 as the locator wire assembly 106is moved through the lateral wire lumen slot 132 and into the wire lumen123. In other arrangements, the sealing pad delivery device 102 may beconstructed to provide one-way insertion of the locator wire assembly106 through the lateral wire lumen slot 132. For example, the locatorwire assembly 106 may move through the lateral wire lumen slot 132 inthe radial inward direction, but is restricted from moving back throughthe lateral wire lumen slot 132 in the radial outward direction.

In at least some methods of use, the sealing pad delivery device 102 maybe mounted to the locator wire assembly 106 in a lateral direction in astep prior to disposing the sealing pad adjacent to the tissue puncture,followed by axial withdrawal of the locator wire assembly 106 out of thesealing pad delivery device 102 after the sealing pad has been disposedadjacent to the tissue puncture. In such a method, one-way insertion ofthe locator wire assembly 106 through the lateral wire lumen slot 132into the wire lumen 123 may have advantages in helping retain thesealing pad delivery device 102 on the locator wire assembly 106 duringtreatment of the patient while still providing the lateral mountingdescribed above.

Referring now to FIGS. 4, 4A and 12, the locator wire assembly 106 isdescribed in further detail. The locator wire assembly 106 may include alocator tube 140, a distal end portion 142, a proximal end portion 144,a handle or housing 146, and a temporary anchor 148. The anchor 148 istypically positioned at the distal end portion 142. The anchor 148 isoperable between a collapsed state or position (see FIGS. 9 and 10) thatpermits advancement of the distal end portion 142 through thepercutaneous incision 118 and vessel puncture 114 into the vesselinterior 116, and an expanded position (see FIG. 4) that restrictswithdrawal in a proximal direction.

The locator wire assembly 106 may further include an anchor actuatorwire 150 (see FIG. 4A) that extends from the anchor 148 proximally tothe handle 146 at the distal end portion 144. A wire actuator 152 may beexposed at the proximal end portion 144 such as, for example, within anactuator slot 154 defined in the handle 146 (see cut out portion of FIG.12). In at least one example, advancing the wire actuator 152 in thedistal direction within the actuator slot 154 (a distal axial directionA₂) expands the anchor 148 into the expanded state shown in FIG. 4.Moving the wire actuator 152 within the actuator slot 154 in theproximal direction A₁ returns the anchor 148 to the collapsed state orposition shown in FIGS. 9 and 10.

When the anchor 148 is in the expanded state shown in FIG. 4, the anchor148 may provide hemostasis (i.e., stop blood flow through the vesselpuncture 114). When in the expanded state shown in FIG. 4, the anchor148 may also provide an anchor function for the sealing pad deliverydevice 102 when disposing the sealing pad adjacent to the vesselpuncture 114. Providing an anchor within the vessel 112 while disposingof the sealing pad may improve alignment of the sealing pad relative tothe vessel puncture 114, which may provide reduced leakage and animproved seal.

The handle 146 may be significantly larger in size than the actuatorfeatures 250, 252 described above with reference to guidewire 206. Theincreased size of handle 146, among other aspects such as, for example,the shape and material composition of handle 146, may provide animproved ease in use of locator wire assembly 106 as compared to theguidewire 206 described above. Other types of actuator arrangementsbesides the wire actuator 152, which is operable within an actuator slot154, may be used to advance and withdraw the anchor actuator wire 150relative to the locator tube 140. In other arrangements, the anchor 148is operable between collapsed and expanded states by moving the wireactuator 152 within the actuator slot 154 in an opposite direction tothat described above. In some examples, thumb or finger actuated devicesincluding, for example, roller actuators, and in some cases electronicor powered devices, may be used to move the anchor between expanded andcollapsed positions. In still further arrangements, the handle 146 andwire actuator 152 may be positioned along the locator tube 140 andanchor actuator wire 150 at locations distal of the proximal end of atleast one of the locator tube 140 and anchor actuator wire 150.

The handle 146 and wire actuator 152 may have any shape or constructiondesired. The construction of handle 146 and wire actuator 152 is notlimited to a size or shape that may be passed through the sealing paddelivery device 102, which is required of the guidewire 206 describedabove with reference to the tissue puncture treatment assembly 200.

Operation of the tissue puncture treatment assembly 100 is now describedin more detail with reference to FIGS. 4-11. The locator wire assembly106 is advanced through the percutaneous incision 118 and vesselpuncture 114 until a distal end portion 142 (including anchor 148) ispositioned within the vessel interior 116. The wire actuator 152 isadvanced within the actuator slot 154 in the handle 146 to expand theanchor 148 into the expanded state shown in FIG. 4. The locator wireassembly 106 is then withdrawn proximally until the anchor 148 engagesagainst the vessel wall adjacent to the vessel puncture 114.

The locator wire assembly 106 may be positioned within the vesselpuncture 114 and percutaneous incision 118 using, for example, anintroducer sheath or similar device. In some instances, the introducersheath is a procedural sheath used for insertion of treatment ordiagnostic instruments into the vessel interior 116 for treatment of thepatient. In at least one example, the insertion sheath may include afeature similar to the lateral wire lumen slot 132 described above withreference to FIG. 3 to permit removal of the insertion sheath from thelocator wire assembly 106 without the need for withdrawing the insertionsheath proximally over the handle 146 and other features at the proximalend portion 144 of the locator wire assembly 106.

Once the locator wire assembly 106 is positioned with the anchor 148contacting the vessel as shown in FIGS. 4 and 5, the sealing paddelivery device 102 may be moved into position laterally or radiallyadjacent to the locator wire assembly 106 as shown in FIG. 5. Typically,the sealing pad delivery device 102 is positioned adjacent to thelocator wire assembly 106 at a location between the distal and proximalend portions 144, 142 of the locator wire assembly 106. The lateral wirelumen slot 132 may be arranged facing the locator wire assembly 106 sothat moving the sealing pad delivery device 102 in the lateral or radialdirection R inserts the locator wire assembly 106 through the lateralwire lumen slot 132 and into the sealing pad delivery device 102.

As described above, the sealing pad 126 may also include a lateral slotopening 136 that is aligned with the lateral wire lumen slot 132 so thatinserting the locator wire assembly 106 laterally into the sealing paddelivery device 102 positions at least a portion of the locator wireassembly 106 within the wire lumen 134 of the sealing pad 126.

After the locator wire assembly 106 has been laterally inserted into thesealing pad delivery device 102 through the lateral wire lumen slot 132(see FIG. 6), the sealing pad delivery device 102 may be advanceddistally in the direction A₂ until at least a portion of the carriertube 122 is positioned within the percutaneous incision 118.

Referring to FIG. 7, once the sealing pad delivery device 102 isarranged at a desired position relative to the vessel puncture 114 inthe percutaneous incision 118 (i.e, as indicated by exposure of a marker156 along the length of the locator wire assembly 106), the wire lockingmember 128 is actuated to fix or lock an axial position of the sealingpad delivery device 102 relative to the locator wire assembly 106. Othermeans of retaining the sealing pad delivery device 102 in a set or fixedaxial position relative to the locator wire assembly 106 may beaccomplished in place of or in combination with use of the wire lockingmember 128. In at least one example, a proximally directed axial forcein the direction A₁ may be applied to the locator wire assembly 106(i.e., at the handle 146) while applying a distally applied axial forcein the direction A₂ to the sealing pad delivery device 102 at the timeof actuating the wire locking member 128 for improved positioning of thesealing pad delivery device 102 adjacent to the vessel puncture 114.

Referring now to FIG. 8, the operator may actuate the tube retractoractuator 130 in the proximal direction A₁ to withdraw the carrier tube122 in a proximal direction thereby exposing the sealing pad 126 withinthe percutaneous incision 118. Once the sealing pad 126 is exposedwithin the percutaneous incision 118, the sealing pad 126 may begin toabsorb fluids (i.e., blood) and being to swell within the percutaneousincision 118 to seal the vessel puncture 114 and percutaneous incision118. The sealing pad 126 may expand to close the lateral slot opening136 as the sealing pad 126 absorbs fluids.

Referring now to FIG. 9, the wire actuator 152 may be actuated withinthe actuator slot 154 to return the anchor 148 to an unexpanded orcollapsed state. The anchor 148 in the unexpanded state may be sized topermit withdrawing of the locator wire assembly 106 proximally throughthe sealing pad 126 and sealing pad delivery device 102. Prior towithdrawing the locator wire assembly 106 relative to the sealing paddelivery device 102, the wire locking member 128 may be released topermit such relative axial movement. With the locator wire assembly 106removed from the sealing pad 126, the sealing pad 126 may continue toabsorb fluids and expand within the percutaneous incision to provideimproved sealing and closure of the vessel puncture 114 and percutaneousincision 118.

The sealing pad delivery device 102 may be retained in a fixed axialposition relative to the sealing pad 126 during withdrawal of thelocator wire assembly 106 as shown in FIG. 10 to help maintain thesealing pad 126 within the percutaneous incision 118. The locator wireassembly 106 may be completely withdrawn out of the sealing pad deliverydevice 102 as shown in FIG. 10 prior to withdrawing the sealing paddelivery device 102 out of the percutaneous incision 118. Alternatively,the locator wire assembly 106 may be withdrawn proximally out of thesealing pad 126 while being at least partially retained within thesealing pad delivery device 102. Subsequently, the sealing pad deliverydevice 102 and locator wire assembly 106 may be withdrawn together outof the percutaneous incision 118.

In an alternative method step, the locator wire assembly 106 may bemaintained in the position shown in FIGS. 8 and 9 after the sealing pad126 has been exposed within the percutaneous incision 118 and while thesealing pad delivery device 102 is withdrawn out of the percutaneousincision 118. The locator wire assembly 106 may then be withdrawnproximally out through the sealing pad 126 and percutaneous incision 118with the sealing pad delivery device 102 still maintained mounted to thelocator wire assembly 106. Alternatively, the sealing pad deliverydevice 102 may be dismounted from the locator wire assembly 106 (i.e.,in the lateral or radial direction) while the locator wire assembly 106remains at least partially inserted through the percutaneous incision118.

FIG. 11 illustrates the sealing pad delivery device 102 withdrawn out ofthe percutaneous incision 118 after the sealing pad 126 has beendisposed within the percutaneous incision 118 and after the locator wireassembly 106 has been withdrawn out of the sealing pad 126 andpercutaneous incision 118.

Many types of anchor structures may be used with the locator wireassemblies described herein. In at least one example, the anchorcomprises an expandable basket or cage-type structure that is coveredwith, for example, a flexible membrane. A wire actuator that extendsalong at least a portion of the length of the locator wire assembly isused to expand and contract the basket or cage structure within themembrane. Other anchor constructions and actuator arrangements arepossible for use in the locator wire assemblies described herein. In oneexample, an inflation balloon is used instead of a mechanically actuatedanchor member. In other examples, the guidewire does not include ananchor member, but does include a handle for improved ease in handlingthe guidewire.

The preceding description has been presented only to illustrate anddescribe exemplary embodiments of the present disclosure. It is notintended to be exhaustive or to limit the invention to any precise formdisclosed. Many modifications and variations are possible in light ofthe above teaching. It is intended that the scope of the invention bedefined by the following claims.

1. A tissue puncture closure assembly, comprising: a wire assemblyincluding: a proximal end portion and a distal end portion; a temporaryexpandable anchor positioned at the distal end portion; a sealing paddelivery device including: a carrier tube; a sealing pad positioned inthe carrier tube; a lateral wire slot defined in an outer surface of thesealing pad delivery device and extending along at least a portion of alength of the sealing pad delivery device, the lateral wire slot beingconfigured to permit mounting of the sealing pad delivery device to thewire assembly in a lateral direction.
 2. The tissue puncture closureassembly of claim 1, wherein the lateral wire slot is configured toprovide a snap-fit connection of the sealing pad delivery device to thewire assembly.
 3. The tissue puncture locator device of claim 1, whereinthe sealing pad delivery device further includes a housing, and thelateral wire slot is defined in outer surfaces of the housing, thecarrier tube, and the sealing pad.
 4. The tissue puncture locator deviceof claim 1, wherein the wire assembly further includes a handlepositioned at the proximal end portion and an anchor actuator mounted tothe handle.
 5. The tissue puncture locator device of claim 1, whereinthe wire assembly includes a tubular portion defining a lumen, and awire member positioned in the lumen, wherein relative movement betweenthe tubular portion and the wire member expands and contracts theanchor.
 6. The tissue puncture locator device of claim 5, wherein thewire assembly further includes an anchor actuator positioned at theproximal end portion and configured to move the wire member relative tothe tubular portion.
 7. The tissue puncture locator device of claim 6,wherein the sealing pad delivery device includes a wire lumen sized toreceive a portion of the wire assembly that is located between thedistal and proximal end portions, and the proximal end portion of thewire assembly is sized greater than the wire lumen.
 8. A tissue punctureclosure device adapted for insertion into and sealing of a tissuepuncture in a tissue wall, the closure device comprising: a housing; acarrier tube extending from the housing; a sealing pad positioned in thecarrier tube; a guidewire lumen extending through the housing andcarrier tube; a lateral guidewire slot that is open from an outer sidesurface of the closure device into the guidewire lumen, the closuredevice being operable to mount to a guidewire that is positioned in thetissue puncture by inserting the guidewire through the lateral guidewireslot and into the guidewire lumen.
 9. The tissue puncture closure deviceof claim 8, wherein a portion of the guidewire located between proximaland distal ends of the guidewire is inserted into the lateral guidewireslot.
 10. The tissue puncture closure device of claim 8, wherein sealingpad includes a slot feature arranged in alignment with the lateralguidewire slot.
 11. The tissue puncture closure device of claim 8,further comprising a wire locking member operable to resist axialmovement of the closure device relative to the guidewire.
 12. The tissuepuncture closure device of claim 8, further comprising an tube retractoractuator operable to withdraw the carrier tube relative to the housingto expose the sealing pad.
 13. The tissue puncture closure device ofclaim 12, wherein the lateral guidewire slot includes a taperedconstruction.
 14. The tissue puncture closure device of claim 13,wherein the lateral guidewire slot is configured to provide a snap-fitconnection between the guidewire and the closure device.
 15. A method ofsealing a tissue puncture in an internal tissue wall that is accessiblethrough a percutaneous incision, the method comprising: providing aclosure device and a guidewire, the closure device including a sealingpad and a lateral guidewire slot, the guidewire including distal andproximal ends; advancing a distal end of the guidewire through thepercutaneous incision and the tissue puncture; mounting the closuredevice to the guidewire by inserting a portion of the guidewire that isspaced between the distal and proximal ends of the guidewire through thelateral guidewire slot.
 16. The method of claim 15, wherein mounting theclosure device includes arranging the closure device laterally adjacentto the guidewire with the lateral guidewire slot aligned facing theguidewire, and moving the closure device in a lateral direction towardthe guidewire.
 17. The method of claim 16, wherein the guidewireincludes a handle positioned at a location proximal of the percutaneousincision when the distal end of the guidewire is advanced through thepercutaneous incision and the tissue puncture, and mounting the closuredevice to the guidewire includes mounting the closure device to theguidewire at a location distal of the handle.
 18. The method of claim15, wherein the lateral guidewire slot is defined at least in part bythe sealing pad, and mounting the closure device to the guidewireincludes inserting the guidewire into the sealing pad.
 19. The method ofclaim 15, further comprising operating the closure device to expose thesealing pad in the percutaneous incision and withdrawing the guidewirethrough the exposed sealing pad.
 20. The method of claim 15, wherein theclosure device includes a carrier tube and a housing, the lateralguidewire slot being defined in the carrier tube and housing, andmounting the closure device to the guidewire includes inserting theguidewire into the carrier tube and housing.